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Sociocultural Influences on Pain Assessment

N/A
Recruiting
Led By Lauren Y Atlas, Ph.D.
Research Sponsored by National Center for Complementary and Integrative Health (NCCIH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All Sub-Studies: Between 18 and 60 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every visit
Awards & highlights

Study Summary

This trial is exploring if social and cultural factors play a role in how people experience pain and how others interpret it. Eligible participants will be asked to complete a series of tests that may include electric shock, thermal stimulation, and viewing images of others in pain.

Who is the study for?
Healthy adults aged 18-60 who speak English fluently and can consent to participate are eligible for this study. Excluded are those with chronic pain conditions, certain medical issues affecting sensation or pain perception, employees of NCCIH and NIMH, non-US residents, and individuals taking specific prescription medications.Check my eligibility
What is being tested?
The trial investigates how social and cultural factors influence the experience of pain and its assessment by others. It involves electric shocks, thermal stimulation via a thermode device, cold water immersion tests, facial expression recording during painful stimuli, heart activity monitoring, sweat measurement sensors on the hand, facial muscle electrical activity testing through electrodes attached to the skin.See study design
What are the potential side effects?
Participants may experience temporary discomfort from electric shocks or thermal stimulations. Cold water immersion could cause brief numbness or tingling in the hand. The adhesive from pads used for monitoring might irritate some people's skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and every visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain perception (pain ratings)
Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position)
Secondary outcome measures
Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Substudy 3: Feedback GroupExperimental Treatment1 Intervention
Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
Group II: Substudy 1: All participantsExperimental Treatment3 Interventions
Measuring facial response to painful stimulation.
Group III: Substudy 2: Healthy volunteersActive Control1 Intervention
Measuring pain assessment accuracy
Group IV: Substudy 3: ControlActive Control1 Intervention
Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cold water bath
2014
N/A
~30

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)Lead Sponsor
832 Previous Clinical Trials
668,333 Total Patients Enrolled
33 Trials studying Pain
19,180 Patients Enrolled for Pain
Lauren Y Atlas, Ph.D.Principal InvestigatorNational Center for Complementary and Integrative Health (NCCIH)
2 Previous Clinical Trials
10,500 Total Patients Enrolled
2 Trials studying Pain
10,500 Patients Enrolled for Pain

Media Library

Cold water bath Clinical Trial Eligibility Overview. Trial Name: NCT03258580 — N/A
Pain Research Study Groups: Substudy 2: Healthy volunteers, Substudy 3: Control, Substudy 3: Feedback Group, Substudy 1: All participants
Pain Clinical Trial 2023: Cold water bath Highlights & Side Effects. Trial Name: NCT03258580 — N/A
Cold water bath 2023 Treatment Timeline for Medical Study. Trial Name: NCT03258580 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for this medical trial?

"The investigation, initially detailed on May 9th 2018, is still actively recruiting research subjects per the information posted to clinicaltrials.gov; with its latest amendment being dated November 16th 2022."

Answered by AI

Is there availability for my involvement in this research project?

"Patients between the ages of 18 and 60, who are suffering from pain, can apply to join this study. A total of 600 individuals will be enrolled in the trial."

Answered by AI

What is the aggregate headcount of individuals taking part in this experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which first opened its doors on May 9th 2018, is actively recruiting applicants. The study needs 600 participants from 1 site to be fully enrolled."

Answered by AI

Does this investigation allow for individuals aged 50 and over to participate?

"The parameters of this medical trial stipulate that prospective participants must fall within the 18-60 age range. 122 studies are available for those under the legal limit and 626 can be found for individuals over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~0 spots leftby May 2024